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NCT03196648 · ClinicalTrials.gov registry record · NA
Randomized Trial of a Gum Health Formulation
A NA study, sponsored by Glo Science.
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
NCT03196648 is a NA study that has completed, run by Glo Science. The registered enrollment target is 39 participants.
The verdict
NCT03196648, a NA study, has completed, sponsored by Glo Science.
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of a newly formulated foaming gel product on gingivitis and/or moderate periodontitis when used with or without the GLO Science accelerating device (GLO Device), compared to standard tooth brushing with antioxidant whitening toothpaste with or without flossing (split mouth design for control group). This is a 60-day randomized single blinded parallel group study. After 42 days, all use of interventional products were discontinued, and the participants returned to the clinical center at day 60 for final measurements. The primary outcomes assessed in this study were the differences in gingival index (GI) and bleeding on probing (BOP) from baseline to 42 \& 60 days. The secondary outcomes are tooth whitening, oral malodor, pocket depth and plaque amount. It is hypothesized that participants using the gingival health product with the GLO Device will experience greater reductions in GI \& BOP measurements than the control group, as well as participants using the gingival health product on a toothbrush alone.
Interventions
- OTHER Gingival health formulation in an accelerating device
- OTHER Gingival health formulation on a toothbrush
- OTHER OTC fluoride toothpaste
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2015-05-01 |
| Est. Completion | 2016-11-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03196648
The ClinicalTrials.gov registry entry for NCT03196648 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Glo Science, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Gingival health formulation in an accelerating device is the first listed.
NCT03196648 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03196648 about?
NCT03196648 is a clinical study titled "Randomized Trial of a Gum Health Formulation". The purpose of this study is to evaluate the safety and efficacy of a newly formulated foaming gel product on gingivitis and/or moderate periodontitis when used with or without the GLO Science accelerating device (GLO Device), compared to standard tooth brushing with antioxidant whitening toothpaste...
What is the current status of trial NCT03196648?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2015-05-01. Estimated completion is 2016-11-30.
What interventions are being tested in trial NCT03196648?
The interventions under investigation include: Gingival health formulation in an accelerating device (OTHER), Gingival health formulation on a toothbrush (OTHER), OTC fluoride toothpaste (OTHER).
Who is sponsoring clinical trial NCT03196648?
This trial is sponsored by Glo Science, which has 3 total clinical trials registered on ClinicalTrials.gov.
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